CARBOGEN AMCIS said its Vionnaz, Switzerland, facility completed its first FDA pre-approval inspection without receiving a Form 483.
The FDA inspected the site from Sept. 7 to 11 as part of its review of a product manufactured there. CARBOGEN AMCIS did not identify the product or its sponsor.
According to the company, inspectors examined manufacturing and batch records, process validation, equipment qualification and analytical method validation. The inspection also covered cleaning validation, supplier qualification, change control, deviations, corrective and preventive actions, and employee training.
A pre-approval inspection assesses a manufacturing site in connection with an application for a specific product. The absence of a Form 483 means the inspection ended without the FDA issuing that document to record observed conditions that may violate regulatory requirements. It does not, by itself, constitute product approval.
CARBOGEN AMCIS acquired the Vionnaz site in 2014. The facility develops and manufactures small quantities of highly potent active pharmaceutical ingredients, including warheads and linkers used in antibody-drug conjugates. It has dedicated areas for process development, production and quality control.
Stephanie Schlienger, the company’s vice president of quality and compliance, described the inspection as a milestone for the facility’s work with highly potent ingredients. Chief Executive Stephan Fritschi thanked staff who prepared for and supported the inspection.
CARBOGEN AMCIS is part of the Dishman Carbogen Amcis Group and provides pharmaceutical process development and active pharmaceutical ingredient manufacturing services. The company did not report an FDA decision on the product under review or provide a timetable for one.